- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the
same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
Important things to know about combined hormonal contraceptives (CHCs)
• They are one of the most reliable reversible methods of contraception if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a
combined hormonal contraceptive following a break of 4 or more weeks.
• Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 ‘Blood Clots’).
What is in this leaflet
1. What Akizza is and what it is used for
2. What you need to know before you take Akizza
3. How to take Akizza
4. Possible side effects
5. How to store Akizza
6. Contents of the pack and other information
1. What Akizza is and what it is used for
Akizza is a combined oral contraceptive, “the Pill”. You take it to stop you getting pregnant.
This contraceptive contains two types of female sex hormones called ethinylestradiol and gestodene. Both hormones prevent the
monthly release of an egg from the ovaries and thicken the mucus in the neck of the womb thereby making it more difficult for the

sperm to reach the egg. Akizza also affects the lining of the womb to make it less likely to accept a fertilised egg.
Akizza will not protect you against sexually transmitted infections, such as AIDS. Only condoms can help to do this.
2. What you need to know before you take Akizza
General notes
Before you start using Akizza you should read the information on blood clots in section 2. It is particularly important to read the
symptoms of a blood clot – see section 2 ‘Blood Clots’.

Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Akizza, you should also tell your doctor.
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);

BLOOD CLOTS IN A VEIN

Like all oral contraceptives Akizza does not protect against HIV infection (AIDS) and other sexually transmitted
diseases. Only condoms can help to do this.

What can happen if a blood clot forms in a vein?
• The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous

Breast cancer has been observed slightly more often in women using oral contraceptives than in women of the same age who do

contraceptive.

not use them. It is not known whether this difference is caused by oral contraceptives. For example it may be that more tumours

• If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).

are detected in users of combined oral contraceptives because they tend to be examined more often. The occurrence of breast

• If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.

tumours becomes gradually less after stopping the Pill. It is important to regularly check your breasts and you should contact your

• Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).

doctor if you feel any lump.

When is the risk of developing a blood clot in a vein highest?

The risk of cervical cancer of the uterus is higher in women taking oral contraceptives. The most important risk factor for cervical

The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first

cancer is persistent infection with the human papillomavirus (HPV). These findings may also have something else in common other

• if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood Clots’);

time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product)

than the use of oral contraceptives (e.g. differences in sexual behavior). In case of abnormal vaginal bleeding with unknown cause,

• if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you

after a break of 4 weeks or more.

consult your doctor.

• if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys);
• if you have sickle cell anaemia (an inherited disease of the red blood cells);
• if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition.
Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);

After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.

can start taking Akizza;
• if you have an inflammation in the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins; if you have diabetes mellitus (diabetes) or susceptibility to its creation;
• if you or your close family have ever had problems with your heart, or circulation such as high blood pressure;
• if you or your close family have ever had problems with blood clotting;
• if you have the inherited disease called porphyria;
• if you are overweight (obese);

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with Akizza is small.

blood clot in a year.

• if you have any illness that worsened during pregnancy or previous use of the Pill.
Blood Clots

- Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone,

- Out of 10,000 women who are using a combined hormonal contraceptive that contains gestodene such as Akizza between
about 9-12 women will develop a blood clot in a year.

• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or ATE).
Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of having a harmful blood clot due to Akizza is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.
What are you possibly suffering from?
Deep vein thrombosis

especially when accompanied by:

your risk of a blood clot” below).
Women who are not using a combined hormonal pill/patch/

Risk of developing a blood clot in a year
About 2 out of 10,000 women

ring and are not pregnant
Women using a combined hormonal contraceptive pill

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Akizza is small but some conditions will increase the risk. Your risk is higher:
• if you are very overweight (body mass index or BMI over 30kg/m2);
In this case you could have a hereditary blood clotting disorder;

standing or walking;

• if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in

o increased warmth in the affected leg;

a cast. The use of Akizza may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop

blood pressure and make sure you are not pregnant. Your doctor may also give you a comprehensive medical examination.

o change in colour of the skin on the leg e.g. turning pale,

Akizza ask your doctor when you can start using it again.

request an additional prescription.
You should not use Akizza if you have any of the conditions listed below. If you do have any of the conditions listed below, you
must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.
Do not use Akizza:
• if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary
embolus, PE) or other organs;
• if you know you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency,
antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• if you need an operation or if you are off your feet for a long time (see section ‘Blood Clots’);
• if you have ever had a heart attack or a stroke;
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart
attack) or transient ischaemic attack (TIA – temporary stroke symptoms);
• if you have any of the following diseases that may increase your risk of a clot in the arteries:
– severe diabetes with blood vessel damage,
– very high blood pressure,
– a very high level of fat in the blood (cholesterol or triglycerides),

red or blue.
• Sudden unexplained breathlessness or rapid breathing;

• as you get older (particularly above about 35 years);
Pulmonary embolism

While using Akizza, blood clots have been observed in the blood vessels of the eye (ocular vascular thrombosis), which may lead to
vision, you should inform your doctor immediately.
The Pill and migraine / headache
If you feel the onset or worsening of migraine or development of headache with new symptoms that recur, persist or are severe,
contact your doctor immediately. During the use of Akizza, if you have a migraine (particularly migraine with aura), you may be
subject to an increased risk of stroke.

Changes in glucose tolerance are observed in women using Akizza. If you have diabetes, your doctor should carefully monitor the
use of Akizza.
If you have high triglycerides (fat) levels, your doctor should carefully monitor the use of Akizza, since there have been rare cases
where a massive increase in triglycerides leads to pancreatitis (inflammation of the pancreas).
The Pill and depression
If you have ever had depression and this depression recurs while you are using Akizza, you should discontinue use and tell your
doctor.
The Pill and its effects on immunity
Use of the product may cause or worsen the symptoms of angioedema (rapid swelling of the tissues which is caused by a problem
with the immune system. In some cases, this causes problems with breathing, swallowing, and rash).
Other medicines and Akizza:

It is also important to tell your doctor or dentist that you are taking Akizza because taking certain other medicines could alter the
effectiveness of Akizza or the other medicines.

known reason, or you gain a lot of weight, tell your doctor.

During use of Akizza with certain other medicines, it is recommended to use additional non-hormonal methods of contraception

BLOOD CLOTS IN AN ARTERY

method for at least another 7 days after stopping certain other medicines while using Akizza.

(such as condoms with spermicide) along with the use of Akizza. It is recommended to use additional non-hormonal contraceptive

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Medicines that can make Akizza less effective in preventing pregnancy include:

• if you have high blood pressure;
• if a member of your immediate family has had a heart attack or stroke at a young age (less then about 50). In this case you

• if you have (or have ever had) breast cancer;

arm and stomach;
• Sweating, nausea, vomiting or dizziness;

• if you have ever had a severe liver disease, and you have been told by your doctor that your liver function test results are not yet

• Extreme weakness, anxiety, or shortness of breath;

• if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides);

Medicines containing troleandomycin may increase the risk of cholestasis (accumulation of bile in the gallbladder) when taken

• Rapid or irregular heartbeats.
• Sudden weakness or numbness of the face, arm or leg,

• if you get migraines, especially migraines with aura;

with the Pill.

– a condition known as hyperhomocysteinaemia;
• if you have (or have ever had) a type of migraine called ‘migraine with aura’;

back to normal;
• if you have ever had liver tumours;
• if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see
also in section Other medicines and Akizza).
• if you are allergic to gestodene, ethinylestradiol, or to any of the other ingredients of this medicine (listed in section 6).
Akizza should not be used by children or after menopause.
Warnings and precautions
When should you contact your doctor?
Seek urgent medical attention
- if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis),
a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood Clots’ (thrombosis) section below).
For a description of the symptoms of these serious side effects please go to the paragraph “How to recognise a blood clot”.

Heart attack

Stroke

especially on one side of the body;

If you have more than one of these conditions or if any of them are particularly severe the risk of developing a blood clot may be

• Sudden trouble seeing in one or both eyes;

increased even more.

• Sudden trouble walking, dizziness, loss of balance or

If any of the above conditions change while you are using Akizza, for example you start smoking, a close family member experiences

coordination;

a thrombosis for no known reason, or you gain a lot of weight, tell your doctor.

• Sudden, severe or prolonged headache with no known cause;
• Loss of consciousness or fainting with or without seizure.

What to do if you experience irregular bleeding / spotting

• Sometimes the symptoms of stroke can be brief with an
almost immediate and full recovery, but you should still seek
urgent medical attention as you may be at risk of another

• Severe pain in your stomach (acute abdomen).

• if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation);
• if you have diabetes.

If you are taking a medication containing flunarizine at the same time as Akizza, this may cause production of breast milk in
women who have not yet had children.
Do not use Akizza if you have Hepatitis C and are taking the medicinal products containing ombitasvir/ paritaprevir/ ritonavir
and dasabuvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme). Your doctor will
prescribe another type of contraceptive prior to start of the treatment with these medicinal products. Akizza can be restarted
approximately 2 weeks after completion of this treatment. See section “Do not use Akizza”.

During the use of Akizza, if you observe irregular bleeding or spotting, especially during the first three months and if bleeding

Akizza with food and drink

continues or repeats, stop taking Akizza, use a non-hormonal method of contraception and consult your doctor.

Akizza may be taken with or without food, if necessary with a small amount of water.

What to do if there is no regular bleeding

Pregnancy, breast-feeding and fertility

Some women may not experience regular bleeding during the tablet-free break. If there is failure of two consecutive regular
Blood clots blocking other blood vessels

• Vitamin C or paracetamol;

bleedings, or if the product is not used according to directions before the first regular bleeding that fails, you should discontinue use
of Akizza and use any non-hormonal method of contraception to prevent pregnancy.

There is no evidence that the use of the Pill in early pregnancy leads to increased neonatal defects. Nevertheless, the Pill should
not be used during pregnancy and the possibility of pregnancy should first be taken into account if you fail to bleed regularly.

The use of oral contraceptives should be stopped until pregnancy is ruled out.
The use of Akizza is generally not advisable when a woman is breast-feeding. If you want to take the pill while you are breast feeding,
you should contact your doctor.

• One tablet forgotten in week 3

- heart attack,

You have two options:

- stroke,

1. Take the forgotten tablet as soon as you remember (even if this means taking two tablets at the same time) and take the tablets

- mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA),

at the usual time. Start the next pack as soon as the previous pack is completed, so no break between packs. You may not

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for

have menstrual period until the end of the second pack, but you may have spotting or breakthrough bleeding during the days of

advice before taking this medicine.

tablet-taking.

Driving and using machines
There is no information suggesting that the use of Akizza affects driving or use of machines.
Akizza contains lactose
If you have been told by your doctor that you have an intolerance to lactose, contact your doctor before using Akizza.
3. How to take Akizza

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no

usual.

• Signs of a severe allergic reaction or worsening of hereditary angioedema:

longer use. These measures will help to protect the environment.

With the above two recommendations, you will remain protected against pregnancy if you forgot one pill in week 3.
• If you forgot one of the tablets in a strip and no bleeding occurs during the tablet-free gap period, you may be pregnant.
Then consult your doctor before starting the next strip.
Several tablets
forgotten in
1 strip

Ask your doctor for advice
Yes
in week 1

Wednesday, take a tablet where “Wednesday” is stated. Follow the direction of the arrow on the strip until all 21 tablets have been
taken.

Had sex in the previous week before
forgetting?
No

After you have taken all 21 pills in the strip, you have a seven day break during which you take no pills. In the course of these 7 pillfree days, bleeding should begin, so called ‘withdrawal bleeding’. Usually bleeding starts on the second or third day of the gap week.
On the eighth day i.e. after the seven-day gap you should start the next strip of tablets, whether your bleeding has stopped or not.
This means that each strip begins on the same day of the week and withdrawal bleeding every month coincides.
Correct use of your tablets will ensure protection against pregnancy whilst you take the tablets and also during the 7 days break.

Only 1 tablet
forgotten
(taken more than
12 hours late)

When can you start with the first strip of Akizza

in week 2

You can start taking Akizza on the first day of your menstrual cycle and you immediately get protection against pregnancy. You may
also start taking Akizza on 2nd to 5th day of the menstrual cycle, but in this case, an additional contraceptive method (e.g. condom)
is recommended for the first 7 days.

previous pill, but not later than the day following the tablet-free days of your previous pill (or after the last inactive-tablet of your
previous pill). If you switch from a combined contraceptive vaginal ring or patch, follow the advice given by your doctor.

Follow the advice given by your doctor.
• After childbirth:
You can start taking Akizza after 21 to 28 days of childbirth. If you start taking pill after 28 days, an additional contraceptive method is
recommended for the first seven days. After childbirth, if you have had sex before starting Akizza, you must first be sure that you are
not pregnant or wait until your next period.
• If you are breast-feeding:
Read the section ‘Pregnancy, breast - feeding and fertility’.
Ask your doctor what to do if you are not sure when to start Akizza.
Use in children and adolescents
There is no data available for use in adolescents below 18 years.
If you take more Akizza than you should
It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit or have some vaginal bleeding.

What Akizza contains

Signs of breast cancer:

The active substances are gestodene and ethinylestradiol.

• dimpling of the skin,

Each tablet contains either

• changes in the nipple,

Gestodene 75 mcg and Ethinylestradiol 20 mcg or

• any lumps you can see or feel.

Gestodene 75 mcg and Ethinylestradiol 30 mcg

Signs of cancer of the cervix:

The other ingredients are:

• vaginal discharge that smells and/or contains blood,

Tablet core:

• unusual vaginal bleeding,

Lactose monohydrate

• pelvic pain,

Maize Starch

• painful sex.

Polyvinyl Pyrrolidone

• severe pain in your upper abdomen,

Tablet film-coating:

• yellow skin or eyes (jaundice),

Composition of Opadry white 03F58750:

• inflammation of the liver (hepatitis),

HPMC 2910/Hypromellose (E464)

• your whole body starts itching.

Titanium dioxide (E171)

Akizza may cause some other side effects and these are shown below:-

or

• stomach ache,

Round, white to off white, biconvex, film-coated tablet debossed ‘A’ on one side and other side plain.

If you vomit within 3-4 hours of taking a tablet or you have severe diarrhea, there is a risk that the active substances in the pill will

Uncommon side effects (between 10 and 100 in every 10,000 users may be affected)

not be fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhea, take another

• being sick and stomach upsets,

Each carton contains blister packed in a sealed tri-laminated pouch.

• migraine,

Morningside Healthcare Ltd

Postponing your period:

• loss of interest in sex,

115 Narborough Road

Although it is not recommended, you can postpone your period by directly consuming Akizza without taking a break from the next

• breast enlargement,

Leicester

• skin rash, which may be itchy.

LE3 0PA

blister and continue this till the end. During the administration of the second blister you can experience minor or menstrual-like
bleeding. Begin by following the regular 7-day rest as usual with your next blister.

Rare side effects (between 1 and 10 in every 10,000 users may be affected)

You should ask your doctor for advice before you decide to postpone your menstrual period.

• poor tolerance of contact lenses,

Change in first day of bleeding:
If you take the tablets as directed, your period / withdrawal bleeding starts during the week off between taking tablets. If you need
to change that day, you can do shorter (but never stretching!) rest interval between taking tablets. For example, if your rest interval
between taking tablets starts on Friday, and you want to change to Tuesday (3 days earlier), you should start a new pack 3 days
earlier than usual. If you make the rest interval between taking tablets very short (for example, 3 days or less) bleeding may not
occur during this period. You can then experience spotting (drops or flecks of blood) or breakthrough bleeding.

• increase of interest in sex,

5 Pavilion Way

• vaginal or breast discharge.

Loughborough
LE11 5GW

Other side effects reported
• Bleeding and spotting between your periods can sometimes occur for the first few months but this usually stops once your body
has adjusted to Akizza. If it continues, becomes heavy or starts again, contact your doctor (see section 4.3).

- kidney or liver problems,
- gall stones,

• If you are less than 12 hours late taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as

If you have any questions on the use of this medicine, ask your doctor or pharmacist or nurse.

the strip. Therefore, you must follow the following rules:
• More than one tablet forgotten in this strip
Please contact your doctor.
• One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Take the
tablets again at the usual time and for the next seven days use an additional contraceptive method such as a condom.
If you had sex in the week prior to the missed tablet, you may be pregnant. In this case please contact your doctor.
• One tablet forgotten in week 2
Take the forgotten tablet as soon as you remember, even if that means that you have two tablets at the same time. Take the
tablets again at the usual time. Contraceptive protection is not reduced and you need not take extra contraceptive precautions.

This leaflet was last revised in June 2017.

Chloasma may be reduced by avoiding too much sunlight and/or UV lamps.

If you are unsure how to do this, ask your doctor for advice.

before trying to get pregnant. You can then easily calculate the expected date of birth.

The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or at the end of

UK

• Chloasma (yellow brown patches on the skin). This may happen even if you have been using Akizza for a number of months.

If you forget to take Akizza

tablets you have forgotten, the greater is the risk of becoming pregnant.

Manufacturer
Morningside Pharmaceuticals Ltd

- persistent itching (pruritus),

• If you are more than 12 hours late taking a tablet, the protection against pregnancy may be reduced. The greater the number of

UK

• losing weight,

reliable methods of birth control. If you want to become pregnant, stop using Akizza and wait until you have a menstrual period,

you remember and then take the following tablets again at the usual time.

Not all pack sizes may be marketed.
Marketing Authorisation Holder

• fluid retention,

You can stop taking Akizza whenever you want. If you do not want to become pregnant, ask your doctor for advice about other

some, ask your doctor or pharmacist for advice.

Each carton contains 1, 3, or 6 blister strips of 21 tablets each.

What to do in case of vomiting or severe diarrhoea

Conditions that may worsen during pregnancy or previous use of the Pill:

Talk to your doctor if you have any of these symptoms. If you have taken too many tablets, or you discover that a child has taken

For Akizza 75 microgram / 30 microgram tablets

For Akizza 75 microgram / 20 microgram tablets

• putting on weight,

possible or 12 hours have passed, you should follow the advice given under section ‘What to do if you forget to take Akizza’.

Talc (E553b)

Round, white to off white, biconvex, film-coated tablet debossed ‘B’ on one side and other side plain.

• feeling sick,

tablet from a reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your pill. If that is not

Macrogol 6000

What Akizza looks like and contents of the pack

Common side effects (between 100 and 1000 in every 10,000 users may be affected)

4. Possible side effects
Like all medicines, Akizza can cause side effects, although not everybody gets them. If you get any side effect, particularly if
severe and persistent, or have any change to your health that you think may be due to Akizza, please talk to your doctor.

thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on

- swelling of body parts (hereditary angioedema),

the different risks from taking combined hormonal contraceptives please see section 2 ‘What you need to know before you use

- an inherited disease called porphyria,

Akizza’.

- cancer of the cervix.

Serious side effects

Tell your doctor, pharmacist or family planning nurse if you are worried about any side effects which you think may be due to

Tell your doctor straight away if you get any of these symptoms after taking your tablets.

Akizza. Also tell them if any existing conditions get worse while you are taking Akizza.

Rare side effects (between 1 and 10 in every 10,000 users may be affected):

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

• harmful blood clots in a vein or artery, for example:

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

- in a leg or foot (i.e. DVT),

By reporting side effects you can help provide more information on the safety of this medicine.

- in a lung (i.e. PE),

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